510(k) · Cleared
ClearedQ50 Plus Stent Graft Balloon Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Qxmedical, LLC · DQY Catheter, Percutaneous
Cleared on Feb 24, 2012 as substantially equivalent to K091624 (Via Biomedical, Inc., 2009) after a 17-day review. Its family tree reaches back 4 generations to 2001. 2 later devices descend from it.
- Decided
- Feb 24, 2012
- Review
- 17 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K003495 (2001). 6 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK003495 Ancure Lliac Balloon CatheterGuidant Cardiac and Vascular Surgery · 2001
- 3 generations backK032869 Cook Coda Balloon CatheterCook, Inc. · 2003
- 2 generations backK050038 Reliant Stent Graft Balloon CatheterMedtronic Endovascular Innovations · 2005
- 1 generation backK091624 Stent Graft Balloon CatheterVia Biomedical, Inc. · 2009
- This deviceK120381 Q50 Plus Stent Graft Balloon CatheterQxmedical, LLC · 2012
- Descendant · cites it directly · 0 of its ownK192786 Gatekeeper Balloon CatheterArch Catheter, LLC · 2020
- Descendant · cites it directly · 0 of its ownK172567 GORE Molding and Occlusion Balloon CatheterW. L. Gore and Associates, Inc. · 2018 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K003495 | Ancure Lliac Balloon Catheter | Guidant Cardiac and Vascular Surgery | 2001 | — |
| −3 | K032869 | Cook Coda Balloon Catheter | Cook, Inc. | 2003 | — |
| −2 | K050038 | Reliant Stent Graft Balloon Catheter | Medtronic Endovascular Innovations | 2005 | — |
| −1 | K091624 | Stent Graft Balloon Catheter | Via Biomedical, Inc. | 2009 | — |
| 0 (this device) | K120381 | Q50 Plus Stent Graft Balloon Catheter | Qxmedical, LLC | 2012 | — |
| +1 | K192786 | Gatekeeper Balloon Catheter | Arch Catheter, LLC | 2020 | — |
| +1 | K172567 | GORE Molding and Occlusion Balloon Catheter | W. L. Gore and Associates, Inc. | 2018 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DQY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DQY device
- #1 K234115 APRO 55 Catheterscore 17.5 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K091624 | Stent Graft Balloon CatheterSummary page 1…, '510(k) Status %J Stent Graft Balloon Catheter Via Biomedical, Inc. K09 1624 Device Description: The QXM~dica1 Stent Graft Balloon Catheter is a multi-lumen catheter which has a compliant polyurethane bal… | 2009 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K192786 (Arch Catheter, LLC, 2020) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K091624.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · DQY
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQY
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQY
1in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · DQY
3,056in 2025
MAUDE reports naming product code DQY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 16 | 85 | 6 | 313 |
| 2008 | 31 | 66 | 12 | 496 |
| 2009 | 37 | 73 | 17 | 819 |
| 2010 | 22 | 74 | 32 | 1,293 |
| 2011 | 36 | 71 | 6 | 1,211 |
| 2012 | 30 | 87 | 2 | 1,191 |
| 2013 | 32 | 92 | 36 (1) | 1,352 |
| 2014 | 19 | 127 | 3 | 1,497 |
| 2015 | 27 | 118 | 3 | 2,337 |
| 2016 | 22 | 117 | 22 (7) | 2,252 |
| 2017 | 26 | 113 | 8 | 2,489 |
| 2018 | 25 | 106 | 2 | 2,855 |
| 2019 | 30 | 111 | 1 | 2,902 |
| 2020 | 20 | 120 | 2 | 2,889 |
| 2021 | 18 | 81 | 2 | 3,006 |
| 2022 | 18 | 74 | 0 | 2,643 |
| 2023 | 18 | 114 | 17 | 3,049 |
| 2024 | 16 | 87 | 1 | 3,190 |
| 2025 | 21 | 115 | 1 (1) | 3,056 |
| 2026 | 11 | 30 | 2 (1) | — |
What is it indicated for?
The Stent Graft Balloon Catheter is intended for temporary occlusion of large vessels, or to expand vascular prostheses.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120381 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120381: Q50 Plus Stent Graft Balloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120381
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026